Diabetes is a disease in which the body does not properly produce or use insulin. Insulin is a hormone that converts sugar, starches and other food into energy for the body. The cause of diabetes is unknown, although both genetic and environmental factors such as obesity and lack of exercise are factors in determining disease development.
Approximately 17 million people in the United States, or 6.2% of the population, have diabetes. Diabetes is the fifth leading cause of death by disease in the United States. While an estimated 11.1 million people have been diagnosed, approximately 5.9 million people (35%) are unaware of affliction by the disease. (www.diabetes.org/info/diabetesinfo.jsp). Future incidence of diabetes is likely to increase, driven by an aging population, increasing incidence of obesity, and overall population growth.
Estimates for the worldwide incidence of diabetes vary greatly. One pharmaceutical industry research group report estimates approximately 135 million cases of diabetes in the world today, most undiagnosed, a number could rise to 300 million by 2025 (IMS Health, www.ims-global.com).
The three major types of diabetes are Type I, Type II, and gestational diabetes. Type I diabetes, also called juvenile diabetes, is usually diagnosed in children and young adults and results from the body's inability to produce insulin, the hormone that enables glucose to enter and fuel cells of the body. An estimated 10% of Americans who are diagnosed with diabetes have type I diabetes. Type II diabetes is the most common form and results from insulin resistance, the body's failure to properly use insulin, combined with relative insulin deficiency. Approximately 90% of Americans diagnosed with diabetes have type II diabetes. Glucose accumulates in the blood rather than entering cells, causing two problems, the immediate energy starvation of cells and long term high blood glucose levels that may permanently damage eyes, kidneys, nerves and/or heart. Pre-diabetes is a condition occurring when blood glucose levels are higher than normal but not insufficient to be type II diabetes. An estimated 16 million Americans have pre-diabetes. Gestational diabetes affects about 4% of all pregnant women, about 135,000 cases yearly in the United States.
Diabetes is often undiagnosed because many symptoms appear relatively harmless. Early detection and treatment can decrease the probability of developing the complications of diabetes.
For the people diagnosed with diabetes, the challenge is to actively and accurately manage diets and exercise programs, while also actively managing blood sugar to maintain glucose levels within an optimal range. The less aggressively blood sugar levels are managed, the higher the risk of development of one or more of the major secondary diseases. Diabetics have extra reason to be mindful of heart and blood vessel disease. Diabetes carries an increased risk for heart attack, stroke, and complications related to poor circulation. Two out of three people with diabetes die from heart disease and stroke. Diabetes is the leading cause of blindness among adults aged 21 to 74. Retinopathy develops in nearly all patients with poorly controlled type I diabetes and in more than 60% of patients with type II diabetes (Cefalu, W. T., Weir, G. C. Patient Care. September, 2003, p. 66). Diabetes accounts for 43% of end-stage renal disease. Kidney failure is treated only by dialysis and kidney transplantation to restore the kidney's blood-cleansing function. One common diabetes complication is diabetic neuropathy, damage to the nerves that run throughout the body, connecting the spinal cord to muscles, skin, blood vessels, and other organs. Up to 70% of people with diabetes suffer from mild to severe neuropathy, in many cases resulting in extremity amputations.
Direct medical and indirect expenditures attributable to diabetes are estimated at $132 billion annually. In 2002, direct medical expenditures alone totaled $91.8 billion including $23.2 billion for diabetes care, $24.6 billion for chronic complications resulting from diabetes; and $44.1 billion for excess prevalence of related medical conditions. Indirect expenditures resulting from lost workdays, restricted activity days, mortality, and permanent disability due to diabetes were estimated to total $39.8 billion. The total cost of diabetes treatment at $131.7 billion in 2002 exceeds the total 2002 cost for treating all forms of cancer, an estimated $107 billion. Some estimate that one of four Medicare dollars goes to diabetic healthcare costs.                “Diabetes imposes a substantial cost burden to society and, in particular, to those individuals with diabetes and their families. Eliminating or reducing the health problems caused by diabetes through factors such as better access to preventive care, more widespread diagnosis, more intensive disease management, and the advent of new medical technologies could significantly improve the quality of life for people with diabetes and their families while at the same time potentially reducing national expenditures for health care services and increasing productivity in the U.S. economy.” (American Diabetes Association. “Economic Costs of Diabetes in the U.S. in 2002”. Diabetes Care 26:917-932, 2003).        
Normal blood glucose levels range between 80 and 120 milligrams/deciliter (mg/dl). For a person with diabetes, maintaining glucose levels within range can be difficult. Calories consumed cause blood sugar levels to rise due to the diabetic's inability or impairment in producing insulin. Accordingly, artificial insulin is to be taken via either a syringe, an insulin pump with an implanted catheter, or an oral medication to bring levels back into the target range. Even with vigilant management, blood sugar levels can drop below the optimal range while sleeping. Many diabetics are awakened at least once in the middle of the night to take a blood glucose measurement.
A blood glucose measurement commonly involves usage of a lancet to prick the skin, a test strip to collect the blood sample, and a glucometer to generate a reading. A typical diabetic tests blood glucose levels an estimated six times per day in a painful and costly process that is difficult to discretely execute in public settings. Should the measurement indicate levels are outside of the optimal range, then either insulin or calories are taken for appropriate correction.